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RISPERDAL ® CONSTA ® (risperidone) LONG-ACTING INJECTION RISPERDAL ® CONSTA ® (risperidone) LONG-ACTING INJECTION prescribing RISPERDAL ® CONSTA ® for patients who will be exposed to temperature extremes. 5.15 Administration RISPERDAL ® CONSTA ® should be injected into the deltoid or gluteal muscle, and care must be taken to avoid inadvertent injection into a blood vessel. [See Dosage and Administration (2) and Adverse Reactions (6.8)] 5.16 Antiemetic Effect Risperidone has an antiemetic effect in animals; this effect may also occur in humans, and may mask signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye’s syndrome, and brain tumor. 5.17 Suicide There is an increased risk of suicide attempt in patients with schizophrenia or bipolar disorder, and close supervision of high-risk patients should accompany drug therapy. RISPERDAL ® CONSTA ® is to be administered by a health care professional [see Dosage and Administration (2)]; therefore, suicide due to an overdose is unlikely. 5.18 Use in Patients with Concomitant Illness Clinical experience with RISPERDAL ® CONSTA ® in patients with certain concomitant systemic illnesses is limited. Patients with Parkinson’s Disease or Dementia with Lewy Bodies who receive antipsychotics, including RISPERDAL ® CONSTA ® , are reported to have an increased sensitivity to antipsychotic medications. Manifestations of this increased sensitivity have been reported to include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with the neuroleptic malignant syndrome. Caution is advisable when using RISPERDAL ® CONSTA ® in patients with diseases or conditions that could affect metabolism or hemodynamic responses. RISPERDAL ® CONSTA ® has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product’s premarket testing. Increased plasma concentrations of risperidone and 9-hydroxyrisperidone occur in patients with severe renal impairment (creatinine clearance
RISPERDAL ® CONSTA ® (risperidone) LONG-ACTING INJECTION RISPERDAL ® CONSTA ® (risperidone) LONG-ACTING INJECTION experiencing adverse events, events were grouped in standardized categories using MedDRA terminology. Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of RISPERDAL ® CONSTA ® (adverse drug reactions) based on the comprehensive assessment of the available adverse event information. A causal association for RISPERDAL ® CONSTA ® often cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The majority of all adverse reactions were mild to moderate in severity. 6.1 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Schizophrenia Table 1 lists the adverse reactions reported in 2% or more of RISPERDAL ® CONSTA ® - treated patients with schizophrenia in one 12-week double-blind, placebo-controlled trial. Table 1. Adverse Reactions in ≥ 2% of RISPERDAL ® CONSTA ® -Treated Patients with Schizophrenia in a 12-Week Double-Blind, Placebo-Controlled Trial Percentage of Patients Reporting Event RISPERDAL ® CONSTA ® Placebo System/Organ Class 25 mg 50 mg Adverse Reaction (N=99) (N=103) (N=98) Eye disorders Vision blurred 2 3 0 Gastrointestinal disorders Constipation 5 7 1 Dry mouth 0 7 1 Dyspepsia 6 6 0 Nausea 3 4 5 Toothache 1 3 0 Salivary hypersecretion 4 1 0 General disorders and administration site conditions Fatigue* 3 9 0 Edema peripheral 2 3 1 Pain 4 1 0 Pyrexia 2 1 0 Infections and infestations Upper respiratory tract infection 2 0 1 Investigations Weight increased 5 4 2 Weight decreased 4 1 1 Musculoskeletal and connective tissue disorders Pain in extremity 6 2 1 Nervous system disorders Headache 15 21 12 Parkinsonism* 8 15 9 Dizziness 7 11 6 Akathisia* 4 11 6 Sedation* 5 6 3 Tremor 0 3 0 Syncope 2 1 0 Hypoesthesia 2 0 0 Respiratory, thoracic and mediastinal disorders Cough 4 2 3 Sinus congestion 2 0 0 Skin and subcutaneous tissue disorders Acne 2 2 0 Dry skin 2 0 0 * Fatigue includes fatigue and asthenia. Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia. Akathisia includes akathisia and restlessness. Sedation includes sedation and somnolence. 6.2 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Bipolar Disorder Table 2 lists the treatment-emergent adverse reactions reported in 2% or more of RISPERDAL ® CONSTA ® -treated patients in the 24-month double-blind, placebocontrolled treatment period of the trial assessing the efficacy and safety of RISPERDAL ® CONSTA ® when administered as monotherapy for maintenance treatment in patients with Bipolar I Disorder. Table 2. Adverse Reactions in ≥2% of Patients with Bipolar I Disorder Treated with RISPERDAL ® CONSTA ® as Monotherapy in a 24-Month Double-Blind, Placebo-Controlled Trial Percentage of Patients Reporting Event System/Organ Class RISPERDAL ® CONSTA ® Placebo Adverse Reaction (N=154) (N=149) Investigations Weight increased 5 1 Nervous system disorders Dizziness 3 1 Vascular disorders Hypertension 3 1 Table 3 lists the treatment-emergent adverse reactions reported in 4% or more of patients in the 52-week double-blind, placebo-controlled treatment phase of a trial assessing the efficacy and safety of RISPERDAL ® CONSTA ® when administered as adjunctive maintenance treatment in patients with bipolar disorder. Table 3. Adverse Reactions in ≥ 4% of Patients with Bipolar Disorder Treated with RISPERDAL ® CONSTA ® as Adjunctive Therapy in a 52-Week Double-Blind, Placebo-Controlled Trial Percentage of Patients Reporting Event RISPERDAL ® CONSTA ® + Placebo + System/Organ Class Treatment as Usuala Treatment as Usuala Adverse Reaction (N=72) (N=67) General disorders and administration site conditions Gait abnormal 4 0 Infections and infestations Upper respiratory tract infection 6 3 Investigations Weight increased 7 1 Metabolism and nutrition disorders Decreased appetite 6 1 Increased appetite 4 0 Musculoskeletal and connective tissue disorders Arthralgia 4 3 Nervous system disorders Tremor 24 16 Parkinsonismb 15 6 Dyskinesiab 6 3 Sedationc 7 1 Disturbance in attention 4 0 Reproductive system and breast disorders Amenorrhea 4 1 Respiratory, thoracic and mediastinal disorders Cough 4 1 a Patients received double-blind RISPERDAL ® CONSTA ® or placebo in addition to continuing their treatment as usual, which included mood stabilizers, antidepressants, and/or anxiolytics. b Parkinsonism includes muscle rigidity, hypokinesia, cogwheel rigidity, and bradykinesia. Dyskinesia includes muscle twitching and dyskinesia. c Sedation includes sedation and somnolence. 6.3 Other Adverse Reactions Observed During the Premarketing Evaluation of RISPERDAL ® CONSTA ® The following additional adverse reactions occurred in < 2% of the RISPERDAL ® CONSTA ® -treated patients in the above schizophrenia double-blind, placebo-controlled trial dataset, in < 2% of the RISPERDAL ® CONSTA ® -treated patients in the above double-blind, placebo-controlled period of the monotherapy bipolar disorder trial dataset, or in < 4% of the RISPERDAL ® CONSTA ® -treated patients in the above double-blind, placebo-controlled period of the adjunctive treatment bipolar disorder trial dataset. The following also includes additional adverse reactions reported at any frequency in RISPERDAL ® CONSTA ® -treated patients who participated in the open-label phases of the above bipolar disorder studies and in other studies, including double-blind, active controlled and open-label studies in schizophrenia and bipolar disorder. Blood and lymphatic system disorders: anemia, neutropenia Cardiac disorders: tachycardia, atrioventricular block first degree, palpitations, sinus bradycardia, bundle branch block left, bradycardia, sinus tachycardia, bundle branch block right Ear and labyrinth disorders: ear pain, vertigo Endocrine disorders: hyperprolactinemia Eye disorders: conjunctivitis, visual acuity reduced Gastrointestinal disorders: diarrhea, vomiting, abdominal pain upper, abdominal pain, stomach discomfort, gastritis
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AVERAGE SALES PRICE (ASP) FOR MEDICARE ... - Janssen CNS

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